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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00717457




Registration number
NCT00717457
Ethics application status
Date submitted
16/07/2008
Date registered
17/07/2008
Date last updated
2/11/2016

Titles & IDs
Public title
A Study of Taspoglutide Versus Exenatide for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin, Thiazolidinedione or a Combination of Both.
Scientific title
Randomized, Active Controlled, Open Label Study to Compare Taspoglutide vs Exenatide as add-on Treatment to Metformin and/or Thiazolidinediones in Patients With Type 2 Diabetes Mellitus
Secondary ID [1] 0 0
2008-001856-36
Secondary ID [2] 0 0
BC21625
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus Type 2 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - exenatide
Treatment: Drugs - taspoglutide
Treatment: Drugs - taspoglutide

Active Comparator: exenatide -

Experimental: taspoglutide 10mg -

Experimental: taspoglutide 10mg/20mg -


Treatment: Drugs: exenatide
5mg twice daily for 4 weeks followed by 10mg twice daily

Treatment: Drugs: taspoglutide
10mg once weekly

Treatment: Drugs: taspoglutide
10mg once weekly for 4 weeks followed by 20mg once weekly

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in HbA1c
Timepoint [1] 0 0
24 weeks
Secondary outcome [1] 0 0
Fasting body weight
Timepoint [1] 0 0
24 weeks
Secondary outcome [2] 0 0
Proportion of patients reaching target HbA1c <=7.0%, <=6.5%
Timepoint [2] 0 0
24 weeks
Secondary outcome [3] 0 0
Relative change in glucose, insulin, C-peptide and glucagon values during a meal tolerance test in a subset of patients.
Timepoint [3] 0 0
24 weeks
Secondary outcome [4] 0 0
Beta cell function (proinsulin/insulin ratio)
Timepoint [4] 0 0
24 weeks

Eligibility
Key inclusion criteria
- adult patients, 18-75 years of age;

- type 2 diabetes receiving metformin and/or pioglitazone or rosiglitazone for at least
12 weeks;

- HbA1c >=7.0% and <=10% at screening;

- BMI >=25kg/m2 (>23kg/m2 for Asians) and <=45kg/m2 at screening;

- stable weight +/- 5% for at least 12 weeks prior to screening.
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- history of type 1 diabetes, diabetes resulting from pancreatic injury or secondary
forms of diabetes;

- history of acute metabolic diabetic complications within the previous 6 months;

- evidence of clinically significant diabetic complications;

- known proliferative diabetic retinopathy;

- myocardial infarction (MI), coronary artery bypass surgery, post-transplantation
cardiomyopathy (PTCM) or stroke within the past 6 months;

- any abnormality in clinical laboratory test or ECG, which precludes safe involvement
in the study as judged by the investigator;

- known hemoglobinopathy or chronic anemia;

- clinically significant gastrointestinal disease.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
- Camperdown
Recruitment hospital [2] 0 0
- Freemantle
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
6959 - Freemantle
Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This 3-arm study will assess the efficacy, safety and tolerability of taspoglutide compared
with exenatide in patients with type 2 diabetes mellitus inadequately controlled with
metformin, thiazolidinedione or a combination of both. Patients will be randomized to receive
taspoglutide (10mg once weekly or 10mg once weekly for 4 weeks followed by 20mg once weekly)
or exenatide (5 micrograms twice daily for 4 weeks followed by 10 micrograms twice daily) in
a ratio of 1:1:1 in addition to continued prestudy metformin and thiazolidinedione either
alone or in combination. The anticipated time on study treatment is 3+ years, and the target
sample size is >500 individuals.
Trial website
https://clinicaltrials.gov/show/NCT00717457
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications